DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The amendment filed May 6, 2026, has been received and entered.
Claims 2, 10, and 14-16 are cancelled. Claims 18-25 are new.
Claims 1, 3-9, 11-13, and 17-25 are examined on the merits.
Inherited Case
Examiner Susan Fernandez has inherited the case from Examiner Gregory Willkeen.
Claim Objections
Claims 1, 3-9, 11-13, and 17-25 are objected to because of the following informalities:
Claim 1 is objected to because it recites “prepared by a method comprises the following steps” in line 7, which is grammatically incorrect. The recitation “comprises” should be changed to the word “comprising.” Since claim 1 is objected to, then the claims incorporating it, claims 3-9, 11-13, and 17-25, are objected to.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3-9, 11-13, and 17-25 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is rendered indefinite by the recitation “a system” in lines 9 and 13. The recitation of a “system” is confusing because it is unclear how it relates to the crushed and sieved dried mulberry leaves combined with water (as in step (1)), the second filter residue combined with water (as in step (3)), or the steps of preparing the mulberry leaf extract. Claim 1 does not recite that the components used in preparing the mulberry leaf extract are provided in a system. Therefore, it is unclear what is meant by “adjusting a pH value of a system.” Since claim 1 is indefinite, then the claims incorporating it, claims 3-9, 11-13, and 17-25, are rendered indefinite. Thus, claims 1, 3-9, 11-13, and 17-24 are rejected under 35 U.S.C. 112(b). For the purpose of applying prior art, “adjusting a pH value of a system to 1.5 to 4” is being interpreted as “adjusting a pH value to 1.5 to 4,” and “adjusting a pH value of a system to 7 to 9” is being interpreted as “adjusting a pH value to 7 to 9.”
Claims 3, 18, and 19 are rendered indefinite by the recitation of a volume ratio that is “1:5-15.” The use of the hyphen in the recitation makes the volume ratio unclear. It is unclear whether the volume ratio is 1:5 to 15 (i.e., 1:5 to 15:1) or 1:5 to 1:15. For the purpose of applying prior art, the recitation “1:5-15” is being interpreted as 1:5 to 15:1.
Claim 6 is indefinite because it is unclear how the enzyme activity has the dimensionless value of 500,000 to 1,000,000. The metes and bounds of the claimed enzyme activity are unclear. Enzyme activity is defined with units in the art in various manners, so it is confusing that the enzyme activity in claim 6 is recited without any units (i.e., dimensionless). For instance, Schisler (US 2009/0017164) discloses acid protease enzyme activity in terms of spectrophotometric acid protease unit (SAPU), wherein 1 SAPU is the amount of protease enzyme activity that liberates one micromole of tyrosine per minute from a casein substrate under conditions of the assay (paragraph [0061]). As another example, Liu (US 2019/0309315) discloses enzyme activity units of an acid protease under the units of U, wherein U/ml of enzyme activity means the amount of enzyme capable of hydrolyzing casein by 1 g of enzyme solution and releasing 1 microgram tyrosine per minute at 40ºC and pH 3.0 (paragraph [0062]).
Notice Re: Prior Art Available Under Pre-AIA and AIA
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-9, 11-13, and 17-25 are rejected under 35 U.S.C. 103 as being unpatentable over Shimakawa (WO 2012/011174 A1. Previously cited. Machine Translation as attached with the Office Action cited below) in view of Cao (CN 111996147 A. Machine Translation cited below. Previously cited), Wang (CN 114177218 A. Machine Translation cited below), and Deng (CN 105154511 A. Machine Translation cited below).
Shimakawa discloses a composition having an action of promoting or improving metabolism of fat, as well as improving obesity (page 2, TECHNICAL-FIELD section). The composition, an anti-obesity agent, comprises an α-glucosidase inhibitor and at least one bacterium which can be lactic acid bacteria (page 33, third paragraph). See also page 16, second paragraph, which discloses a composition containing an α-glucosidase inhibitor and at least one bacterium which can be lactic acid bacteria, that is made into a powder (page 16, second paragraph). Shimakawa discloses that the lactic acid bacteria can be Lactobacillus paracasei subsp. paracasei (page 9, last paragraph). Also, Shimakawa discloses that the α-glucosidase inhibitor can be mulberry leaf extract (page 9, fourth paragraph). It would have been prima facie obvious to the skilled artisan to combine any of the embodiments disclosed in Shimakawa for their invention, including selecting L. paracasei as the bacterium and mulberry leaf extract as the α-glucosidase inhibitors in their composition in which the bacterium is in powder form (at least as in the composition on page 16, second paragraph). Therefore, Shimakawa renders obvious an anti-obesity agent comprising Lactobacillus paracasei powder and a mulberry leaf extract, meeting limitations of the claimed invention.
Regarding the concentrations of the components of the composition, Shimakawa discloses that the amount of the α-glucosidase inhibitor contained in the preparation can be selected from the range of about 0.0001 to 99% by mass in the final preparation, and the at least one bacterium (e.g. a lactic acid bacteria) contained in the preparation is usually selected from the range of 0.000001 to 99% by mass in the final preparation (page 15, second paragraph). Moreover, Shimakawa discusses the combination ratio of the α-glucosidase inhibitor to the at least one bacterium in the composition (page 15, last paragraph). It is preferred that there is 103 to 1012 bacteria for about 0.05 to 500 mg, and about 105 to 1011 bacteria for about 0.01 to 300 mg of the α-glucosidase inhibitor (page 15, last paragraph). Before the effective filing date of the claimed invention, it would have been a matter of routine experimentation to vary the concentrations of the Lactobacillus paracasei powder and the mulberry leaf extract, including to the amounts of 5-10 parts of the L. paracasei powder and 25-75 parts of the mulberry leaf extract, in the composition rendered obvious by Shimakawa, since Shimakawa discloses broad ranges of concentrations and combination ratios that would have necessarily included the claimed amounts and because Shimakawa discloses doses for the α-glucosidase inhibitor and the at least one bacterium for administration to a subject (page 16, last paragraph through page 17, first paragraph) which suggests that their amounts are result-effective variables affecting the health benefits (lipid metabolism, improving obesity) in a subject. As indicated in MPEP 2144.05(II)(A), “‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” Moreover, Shimakawa discloses that the bacterium can be provided as dried bacterial cell product that preferably has particle sizes of 1 to 10 µm (page 11, second paragraph), as well as further disclosing the process by which the dried bacterial cell product is obtained from a bacterial cell liquid (page 12 through page 13, second-to-last paragraph). It would have been obvious to apply that process to obtain the L. paracasei powder for inclusion in the composition rendered obvious by Shimakawa. In doing so, it would have been an obvious matter of routine experimentation that a range of L. paracasei powder can be obtained depending on the starting bacterial cell liquid (the concentration of the bacteria in the liquid that is dried), including a L. paracasei powder containing 2 × 1011 CFU/g L. paracasei.
In sum, Shimakawa renders obvious an anti-obesity composition comprising 5-10 parts of Lactobacillus paracasei powder and 25-75 parts of a mulberry leaf extract, wherein the L. paracasei powder contains 2 × 1011 CFU/g of the L. paracasei, meeting limitations of the claimed invention.
Shimakawa differs from the claimed invention in that Shimakawa does not expressly disclose:
The Lactobacillus paracasei is Lactobacillus paracasei HCS17-040; and
The mulberry leaf extract is prepared by a method comprising steps (1)-(4) recited in instant claim 1.
Regarding difference (1) (Shimakawa does not expressly disclose that the L. paracasei is L. paracasei HCS17-040):
Cao discloses the use of Lactobacillus paracasei HCS17-040 for the purpose of reducing triglyceride or treating hyperlipidemia (Claims 1 and 2 of Cao). Cao points out that the HCS17-040 strain has very excellent triglyceride-reducing function, which is obviously better than an existing strain (abstract).
Before the effective filing date of the claimed invention, it would have been obvious to the person of ordinary skill in the art to substitute the Lactobacillus paracasei with Lactobacillus paracasei HCS17-040 in the composition rendered obvious by Shimakawa. It would have been an obvious matter of simple substitution of one known L. paracasei for another L. paracasei for the predictable result of providing a composition comprising an L. paracasei powder and a mulberry leaf extract for promoting or improving metabolism of fat, and improving obesity. Moreover, the person of ordinary skill in the art would have been motivated to select the HCS17-040 strain as the L. paracasei for inclusion in the composition rendered obvious by Shimakawa because the HCS17-040 has an excellent triglyceride-reducing function and suitable for treating hyperlipidemia, which would have been desirable for a subject that is administered the composition of Shimakawa for promoting/improving fat metabolism and improving obesity sought.
Regarding difference (2) (Shimakawa does not expressly disclose that the mulberry leaf extract is prepared by a method comprising steps (1)-(4) recited in instant claim 1):
Wang discloses a method for preparing a mulberry leaf extract comprising drying and crushing a mulberry leaf to obtain mulberry leaf powder (Step 1 in abstract; page 7, Example 1 section). Then, water is added at 70ºC for ultrasonic treatment for 2 hours, and then the materials are centrifuged to obtain a supernatant 1 and a residue (Step 2 in abstract; page 7, Example 1 section). Water is added to the residue, the pH of the material liquid is adjusted to 4.5, a complex enzyme 1 is added so that the hydrolysis process at 55ºC is performed for 3 hours (page 8, second paragraph). Then, the pH is adjusted to 7.8, a complex enzyme 2 is added, and enzymolysis is continued at 55ºC for 3 hours (page 8, second paragraph). After the enzymolysis, the materials are centrifuged to obtain supernatant 2 (page 8, second paragraph). The supernatant 1 and supernatant 2 are mixed, membrane filtration is performed, followed by membrane concentration and spray draying to obtain the mulberry leaf extract (abstract; page 8, third to sixth paragraphs). Wang states that the mulberry leaf extract obtained by their method has a high extraction rate, the active ingredient in the mulberry leaf are largely kept, the extract has a strong hypoglycemic effect (abstract).
Deng discloses a method of extracting amino acid from mulberry leaves comprising a pre-processing in which the mulberry leaves are dried and then crushed until the granularity is 200-600 meshes to obtain the mulberry leaf powder (abstract; page 2, last paragraph). Then, extraction is performed comprising enzyme treatment and ultrasonic processing (abstract; page 3, first two paragraph). Regarding the enzyme treatment, water is added to the mulberry leaf powder, the temperature is adjusted to 30-55ºC, and an enzyme complex comprising acid protease is added (page 3, first paragraph). After the ultrasonic processing, a solution is obtained, and active carbon is added to the solution to decolor it (page 3, third paragraph). Then, filtering, decompressing, and concentrating the filtrate is performed (page 3, third paragraph). Deng states that their enzyme and ultrasonic treatments have various benefits, including breaking cell walls, improves oligopeptide content of the raw material, and improves the yield and extraction efficiency (abstract; page 2, fifth paragraph).
Instant claims 1, 3-8, and 18-25 are product-by-process claims. Instant claims 9, 11-13, and 17 are method claims which do not explicitly recite performing steps (1)-(4) of instant clam 1 as they recite a method for preparing a product-by-process (instant claims 9 and 11-15) or using the product-by-process (instant claim 17). As stated in MPEP 2113(I), “‘[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.’ In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).”
Before the effective filing date of the claimed invention, for the composition rendered obvious by Shimakawa in view of Cao, it would have been obvious to the person of ordinary skill in the art to prepare the mulberry leaf extract by the method of Wang or the method of Deng. One of ordinary skill in the art would have been motivated to do this because they each have advantages: the method of Wang has a high extraction rate, the active ingredients in the mulberry leaf are largely kept, and the extract has a strong hypoglycemic effect; the method of Deng improves the yield and extraction efficiency. Alternatively, it would have been obvious to the person of ordinary skill in the art to prepare the mulberry leaf extract of the composition rendered obvious by Shimakawa in view of Cao with the method of Wang in which acid protease is included in at least one of the complex enzymes. One of ordinary skill in the art would have been motivated to modify the method of Wang, as applied to the composition rendered obvious by Shimakawa and Cao, to include an acid protease because an acid protease is an enzyme appropriate for the extraction of mulberry leaves, as demonstrated in Deng. A mulberry leaf extract prepared by the method of Wang, the method of Deng, or their combination (inclusion of acid protease in complex enzyme(s) of Wang) appears to be the same as a mulberry leaf extract prepared a method comprising steps (1)-(4) as recited in the instant claims (instant claims 1, 3-8, and 18-25), because the mulberry leaf is extracted using an enzyme (in particular, an acid protease as in Deng) and the similarities in the steps of Wang and Deng with the claimed steps.
Therefore, Shimakawa in view of Cao, Wang, and Deng renders obvious instant claims 1, 3-8, and 18-25.
Regarding instant claims 9 and 11-13, Shimakawa discloses that the preparation of their composition is performed by mixing both components (the α-glucosidase inhibitor, the at least one bacterium) according to a conventional method of preparation (page 15, last paragraph). Furthermore, Shimakawa discloses obtaining a uniform mixture (page 16, fourth paragraph). In mixing the L. paracasei HCS17-040 powder with the mulberry leaf extract for preparing the composition rendered obvious by Shimakawa in view of Cao, Wang, and Deng, it would have been obvious to the person of ordinary skill in the art to evenly mix them since Shimakawa sought a uniform mixture. Therefore, instant claims 9 and 11-13 are rendered obvious.
Regarding instant claim 17, Shimakawa discloses a method for improving or treating obesity as well as a method for improving lipid metabolism, wherein the α-glucosidase inhibitor is administered to an animal in combination with the at least one bacterium (page 20, fourth and sixth paragraphs). Improving or treating obesity is directed to losing weight, and improving lipid metabolism is directed to reducing weight. Therefore, instant claim 17 is rendered obvious.
Response to Arguments
Applicant’s arguments, filed May 6, 2026, with respect to the rejection under 35 U.S.C. 112(a) of claims 1-17, the rejections under 35 U.S.C. 112(b) of claims 1-17, the rejection under 35 U.S.C. 101 of claim 17, and the rejection under 35 U.S.C. 103 of claims 1-17 as being unpatentable over Shimakawa and Cao have been fully considered and are persuasive. In particular, the rejection under 35 U.S.C. 112(a) has been overcome in view of Exhibit I and Exhibit II (Declaration of Public Availability of Deposit) filed May 6, 2026. The rejections under 35 U.S.C. 112(b) have been overcome by the amendments to claims 1, 3, 4, 8, and 17. The rejection under 35 U.S.C. 101 has been overcome by the amendment to claim 17. The rejection under 35 U.S.C. 103 over Shimakawa and Cao has been overcome by the argument that Shimakawa does not explicitly disclose the combination of a Lactobacillus paracasei and mulberry leaf extract, and the argument concerning the amounts of the two components in the composition of Shimakawa (page 15-16 of the Remarks). Therefore, these rejections have been withdrawn.
However, upon further consideration, new grounds of rejection are made in view of the previously cited reference Shimakawa in combination with the previously cited reference Cao and the newly cited references Wang and Deng, and indefinite language in the claims. The Machine translation of the Shimakawa attached to the instant Office Action is cited in the rejection. To the extent Applicant’s arguments are directed to the new grounds of rejection under 35 U.S.C. 103, they are unpersuasive.
In particular, Applicant points to the teaching of preferred α-glucosidase inhibitors in Shimakawa, arguing that the preferred α-glucosidase inhibitors are compounds with defined structures represented by formulas, rather than food extract mixtures that have α-glucosidase inhibitory activity. Applicant also cites Examples 1-5 of Shimakawa as not involving any dietary extract, much less mulberry leaf extract. Applicant also asserts that, based on Shimakawa, mulberry leaf extract is only briefly mentioned, with an asserted low selection priority, and asserted to be almost not recommended – however, the Examiner disagrees with this characterization in Shimakawa. Given these arguments, Applicant concludes that a person skilled in the art would not have motivation to select mulberry leaf extract based on what Shimakawa actually discloses. However, MPEP 2123(II) states, “Disclosed examples and preferred embodiments do not constitute a teaching away from broader disclosure or nonpreferred embodiments.” Moreover, see MPEP 2123(I), which indicates “A reference may be relied upon for all that it would have reasonably suggested to one having original skill in the art, including nonpreferred embodiments.” Though Shimakawa does not teach that mulberry leaf extract is a preferred α-glucosidase inhibitor or disclosed in any example, the teaching of mulberry leaf extract in Shimakawa can be relied upon.
Applicant also points out that Shimakawa lists numerous exemplary combinations of bacteria and α-glucosidase inhibitors which do not include the combination of Lactobacillus paracasei and mulberry leaf extract, and it is argued that a person of ordinary skill in the art would have no motivation to select L. paracasei, no motivation to select mulberry leaf extract, and no motivation to combine the two. However, as set forth in the rejection above, it would have been prima facie obvious to select any combination of the embodiments taught by Shimakawa for the practice of their invention, including the combination of L. paracasei and mulberry leaf extract.
Additionally, Applicant asserts that Cao never suggests combining L. paracasei HCS17-040 with any other component, so a person skilled in the art would not derive any motivation to combine L. paracasei with mulberry leaf extract. However, as explained above, the combination of L. paracasei with mulberry leaf extract would have been obvious since it would have been an obvious matter of selecting embodiments taught by Shimakawa for the practice of their invention. While Cao does not expressly disclose combining L. paracasei HCS17-040 with any other component, Shimakawa renders obvious the combination of L. paracasei with mulberry leaf extract, and as set forth in the above rejection, it would have been an obvious matter of simple substitution to substitute the L. paracasei with the HCS17-040 strain of Cao.
Applicant cites the data in Tables 3-5 of the present application, particularly the data of Example 5 versus Comparative Example 3, asserting that they show that the weight loss and fat reduction effects of the present application are not achieved by any arbitrary combination of lactic acid bacterium and mulberry leaf extract. However, the differences would have been expected because Cao discloses that Lactobacillus paracasei HCS17-040 is useful for reducing triglyceride or treating hyperlipidemia (Claims 1 and 2 of Cao), and the HCS17-040 strain has very excellent triglyceride-reducing function, which is obviously better than an existing strain (abstract). Applicant argues that Cao only verified the single effect of lowering triglycerides by the HCS17-040 strain, while the specific combination of the instant application had multi-dimensional effects. However, the other argued effects would have resulted from the lowering of triglycerides. Thus the multi-dimensional effects would have been expected based on Cao.
Applicant argues that the experimental data of the present application fully demonstrate the synergistic effect and unexpected technical effect of the combination of the instant application. Regarding the mulberry leaf extract, Applicant cites Table 1 of the present application for demonstrating effects significantly superior to those of a positive control group (glucose) and a commercially available mulberry leaf extract. Applicant also cites Tables 3-4, particularly Example 5 compared to Comparative Example 1 and Comparative Example 2, and Comparative Examples 4-5. However, the new grounds of rejection under 35 U.S.C. 103 rely on Wang and Deng for rendering obvious a mulberry leaf extract that appears to be the same as the claimed mulberry leaf extract due to the similarity of the methods of Wang and Deng with steps (1)-(4) of the claimed invention; in particular, the use of enzyme for extraction of the mulberry leaf.
Conclusion
No claims are allowed.
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Sef
/SUSAN E. FERNANDEZ/ Examiner, Art Unit 1651
